The three products all used Acura's AVERSIONTechnology, and they will return to Acura, said termination becoming effectivein 12 months under the terms of Acura's license agreement with a subsidiary ofPfizer.
The products being returned are oxycodone hydrochloridewith acetaminophen, hydrocodone bitartrate with acetaminophen and anundisclosed opioid. The hydrocodone product is the most advanced indevelopment, with a clinical study completed in February 2012 that reportedly demonstratedbioequivalence to its reference-listed drug. This product also was the subjectof a pre-IND meeting held with the U.S. Food and Drug Administration (FDA) inMay 2012 in which the FDA agreed to a development program for this productgenerally consistent with that used for another drug using the AVERSIONtechnology, known as OXECTA (oxycodone hydrochloride) Tablets CII.
"We are pleased to regain control of thesetamper-resistant opioid products because we continue to believe they holdpromise in combating widespread prescription opioid abuse," said BobJones, president and CEO of Acura Pharmaceuticals. "We will evaluate ourstrategy for these products over the coming months, including possiblepartnering with alternative strategic partners, and will work with Pfizer toexercise our rights under the Pfizer agreement for the transition of these productsback to us."
As for OXECTA, that drug is being commercializedby Pfizer and Pfizer will retain all rights and obligations to OXECTA under thelicense agreement.
